Home to Molecular scientists credited with over 50 patents, PathogenDx invented the Microarray technology to enable multiplex testing of multiple pathogens in a single sample. For human, food, agriculture or the environment, now one test drives simplicity, cost savings and class-leading accuracy.
Instead of growing cultures in Petri dishes, DNA-based detection and quantitation delivers maximum detection down to 0.1 CFU for pathogenic organisms. In just 6 hours, laboratories and their customers know the contaminants they need to address.
KEEPING THE FLOW OF BUSINESS
AND TESTING FRICTIONLESS.
With PathogenDx, labs operate at the speed of business, efficiently meeting the testing regulations and minimizing re-testing and reducing economic loss. While healthcare, food & agriculture companies ensure efficient operations. Overall, health threats can be stopped before they start.
PathogenDx testing technology is flexible, and can be performed with equipment available in most labs. Additionally, each well in our multiplex microarray is foil sealed, enabling full use of testing consumables in meeting daily capacity, while minimizing waste.
For Cannabis and Hemp testing, this assay detects bacterial and fungal species in a single well and a single test. Dramatically reduces hands-on steps and cost with results in 6 hours or less. Overnight enrichment is not necessary and optional dependent on state-level testing regulations. Additional reagents available for LIVE organism testing.
Click for list of specific pathogens
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Detect tests are validated down to 1 CFU (Colony Forming Units) detection of Listeria monocytogenes, Listeria spp, Salmonella spp, E. coli (pathogenic and non pathogenic), Pathogenic E. coli genes Stx1/2, Campylobacter spp, Staphylococcus aures, Pseudemonas aeruginosa, and Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus.
Combined Bacterial and fungal detection
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For detection of Aspergillus Flavus, Aspergillus Fumigatus, Aspergillus Niger, and Aspergillus Terreus, Pathogenic Ecoli and Salmonella at 1 CFU/g .
Detection of multiple Pathogens down to 1CFU
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Dual Hybridization of bacterial and fungal pathogens as DetectX Bacterial and DetectX Fungal. This product will save time, consumables and reporting efforts allowing for faster turnaround time.
COVID-19 testing & surveillance
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DetectX-Rv test is based on end-point reverse transcription polymerase chain reaction (RT-PCR) coupled to DNA microarray hybridization for the detection of multiple genes within the SARS-CoV-2 virus.
Viruses including SARS-CoV-2
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Intended for the qualitative detection of N1 and N2 regions of SARS-CoV-2 viral genome in nasopharyngeal, nasal, and oropharyngeal swab specimens from individuals suspected of COVID-19 by their healthcare provider. This test is based on an initial reverse transcription polymerase chain reaction (RT-PCR) amplification and subsequent detection of target SARS-CoV-2 molecules by DNA microarray hybridization. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meets requirements to perform high complexity tests
SARS-CoV-2 clade variant detection
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Identification of SARS-CoV-2 Clade Variants from a positive COVID-19 PCR test
All known SARS-CoV-2 Clade Variants
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Identification of the following Clade Variants: UK (B.1.1.7), South African (B.1.351), Brazillian (P1, P2), California-USA (B.1.429), India (N440K)
Same-Day AOAC-Certified Food Pathogen Detection
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Detection of bacterial pathogen species level testing in food matrices. Overnight enrichment or shortened enrichment will be required.
Listeria spp, L. mono, salmonella ...
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Detection down to 1 CFU of Listeria spp, Listeria Monocytogenes, Pathogenic Ecoli, Campylobacter and Salmonella Enterica to 1 CFU/g.
Environmental Safety Solutions
"Early warning" Surface & Air pathogen detection
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Environmental Screening test for the presence or absence of 30+ bacterial and/or fungal pathogens as well as broad class indicators. This assay can be utilized with multiple sample collection types, including but not limited to food, cannabis and agriculture products, environmental or carcass swabs, air sampling and water sampling.
"Early warning" Surface & Air SARS CoV-2 detection
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The PathogenDx EnviroX-Rv uses endpoint PCR + DNA microarray technology to detect SARS-CoV-2 from stainless steel environmental sample swabs.
Viruses including SARS-CoV-2 and others
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Targets N1, N2 and N3 targets of the SARS-CoV-2 viral genome for detection on stainless steel (Does not preclude detection on plastic, rubber and sealed concrete)
Performance Tested Method Status by the AOAC Research Institute for the multiplex detection of Salmonella spp., Listeria spp., and L. monocytogenes without an enrichment step. 4 different commonly used food surfaces. The assay is validated down to 1 CFU without the need for sample enrichment. Surface & Air SARS CoV-2 detection
Listeria spp, Listeria monocytogenes and Salmonella
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on rubber, plastic, stainless steel and sealed concrete to 1 CFU/gram.
Quantification Solutions
Quantification for bacterial and fungal pathogens
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The QuantX test - Bacterial and Fungal assay provides a semi-quantitative analysis of several broad class indicators. The assay can be used in parallel with the DetectX assay, without the need for enrichment and additional sample preparation, to meet all state cannabis regulations. This product can also be used for optional testing of Food applications.
Multiple Yeasts and Molds
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Total Aerobic, Bile Tolerant Gram Negative, Enterobacteriaceae/Coliform, and Total Yeast and Mold. from 100 to 100,000 CFU/gram
Live vs. Dead
All Products
Isolation of "live" DNA for pathogen detection
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Sample preparation to prevent non-viable cells from being amplified preventing false positives. This product is a supplement to current sample preparation methods.
PARTNERING WITH LEADERS.
A few of our noteworthy partnerships, affiliations and certifications.
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Life Sciences:
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Cannabis:
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Food Safety:
SCANNING — After the sample has gone through hybridization, washing and drying, the 96-well plate is placed in the scanner. The scanner will image each well, illuminating the fluorescent dye, and taking multiple images of each well. The images are then uploaded to our proprietary Augury software where the fluorescent signals are recorded. If the signal is above the threshold for detection, the Augury software will report that sample as being positive for a specific pathogen.
HYBRIDIZATION — After the sample has been amplified via PCR, the amplified product is labeled with a fluorescent dye that is used for detection. The amplified and labeled sample is then mixed with a hybridization buffer and added to a single well. If a pathogen is present and amplified during PCR, the labeled DNA containing it will hybridize to the complementary probe. Each well is then washed and dried prior to scanning.
INSIDE THE WELL — Each well of the PathogenDx DNA Microarray is printed with single stranded DNA probes that are complementary to our amplified PCR products. The probes are coded to identify the presence of unique pathogens (bacteria, fungi, and viruses) as well as probes to discriminate different strains, variants or serovars of these pathogens. Each well of the DNA Microarray can identify up to 50 different pathogens, in triplicate, in a single test.
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